ObesityAMOS2NCT02378259
Randomized Clinical Trial; Medical vs Bariatric Surgery for Adolescents (13-16 y) With Severe Obesity
A study testing Laparoscopic Roux-en-Y gastric bypass and Intense conservative treatment in people with Obesity and Diabetes, run by Göteborg University at 3 sites in Sweden.
Trial summary
Severe childhood obesity is associated with both immediate and chronic health problems and a severe impact on psychosocial development. Medical and behavioural interventions rarely result in the significant, durable weight loss necessary to improve health outcomes. Read more about this study
- Who is it for?
- Ages 13 to 16 years
- Conditions the study is for
- Obesity, Diabetes, Hypertension
- What is being tested?
- Laparoscopic Roux-en-Y gastric bypass and Intense conservative treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 3 sitesSweden
- Study dates
- 15 Aug 2014to Jun 2034
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 13-16 years
- BMI >35
- Failed comprehensive treatment for obesity > 1 year
- Passing assessment of psychologist
- Tanner 3 or more
Who cannot join
- Monogenic obesity (for example Prader Willis, Laurence Moon-Bardet-Biedl)
- Obesity secondary to brain injury
- Severely mentally disabled
- Not eligible for general anesthesia
- Psychotic or other major psychiatric illness
- Previous major gastrointestinal surgery
Trial locations and contacts
3 sites in 1 country.
Sweden3 sites
Sahlgrenska University hospital
Gothenburg, 41345
Skåne University Hospital
Malmö
Karolinska University hospital
Stockholm
About this study
Official title: AMOS2 (Adolescent Morbid Obesity Surgery)
Severe childhood obesity is associated with both immediate and chronic health problems and a severe impact on psychosocial development. Medical and behavioural interventions rarely result in the significant, durable weight loss necessary to improve health outcomes.
This is a randomised clinical trial where 50 adolescents, 13-16 years of age, will be randomised to either early bariatric surgery (Roux-en-Y gastric bypass) or intense conservative treatment and possibly surgery after two years of non-surgical treatment or as they have become 18 years.
Read the detailed description
A multicentre randomised clinical trial where three tertiary referral hospitals recruit patients.
Patients and their parents receive information about the study at their paediatric clinic and at the trial web page (www.amos2.se). Standardised procedure, including signed informed consent.
Interventions
At the end of day of baseline examination patients are randomised to either of two arms:
- Bariatric surgery with regular follow up
- Optimised conservative treatment starting with an 8-week Low Calorie Diet period followed by tailored support and treatment by the multidisciplinary team with an intensity of at least one visits a month over at least 2 years
Patients in the conservative arm will be reassessed regarding interest of undergoing bariatric surgery two years after inclusion.
Sample Size A sample size of 50 (25+25) leaves a power of more than 95% to evaluate a possible superiority of >10% weight difference between the two groups, assuming a 15% standard deviation in weight loss over follow-up at 2.5% significance level.
This number also allows assessment for differences in cardiovascular risk factors with sufficient power and acceptable power for demonstrating differences in quality of life and cognitive functions.
3.6 Randomization The computerized random allocation is performed during the day of baseline examination and patients were informed of their assignment. Forty-nine patients have been included until May 2017, and the last patient will be operated on June 14th. Stratification has been performed according to the recruitment centre
3.8 Statistical Methods \& Additional Analyses Safety \& Efficacy Outcomes: Analyses will be by intention to treat, including all randomised patients. Difference in treatment effect will be evaluated with hazard ratio between the treatment groups, and the corresponding confidence interval will be calculated. For secondary outcomes, the incidence of comorbidities during follow-up will be evaluated using time-to-event models, and for continuous variables mixed models will be used to evaluate differences between the treatment groups.
Incremental cost-effectiveness analysis will be conducted by calculating the incremental cost-effectiveness ratio (ICER; dividing the between-group difference in costs with the between-group difference in quality-adjusted life-years (QALYs) as well as life-years). Probabilistic sensitivity analysis will be conducted and results presented in an ICER scatterplot and cost-effectiveness acceptability curve.
Follow-Up Clinical Data Collection: Study point are 6 weeks, 1 year, 2 years, and 5 years after the start of intervention. Weight, quality of life, and adverse events, as well as clinical data regarding treatments for co-morbidities. Blood sampling for assessment of nutritional deficiencies, glucose control, blood lipids and inflammation will be collected at baseline and 1, 2 and 5 years.
Cognitive functions: Assessments will be performed at baseline and 1 and 2 years after start of intervention.
Register-Based Data Collection and Health-Economic Outcomes: Collection and analysis of Swedish national health care and other official registries
We decided in the Study Steering Committee to change time points for long term follow up to be 5, 10 and 15 years after treatment initiation to better comply with standard schedules for clinical follow up in registers (instead of 7, 12 and 17y after treatment initiation).
- Conditions
- Obesity, Diabetes, Hypertension, Steatohepatitis, Inflammation
- Being tested
- Laparoscopic Roux-en-Y gastric bypass, Intense conservative treatment
- Medical subject headings
- Obesity, Diabetes Mellitus, Hypertension, Fatty Liver, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic Roux-en-Y gastric bypassProcedure or surgery
Bariatric surgery with Roux-en-Y gastric bypass as preferred option, possible laparoscopic Vertical Sleeve Gastrectomy
Intense conservative treatmentProcedure or surgery
Intense medical treatment for obesity (behavioral treatment, dietary intervention, exercise, medication etc) 8 week period of Low Calorie Diet. Treatment intensity about 1 visit a month over 2 years
| Study group | Role | What they receive |
|---|---|---|
| Bariatric surgery | Experimental | Roux-en-Y gastric bypass surgery Receives: Procedure: Laparoscopic Roux-en-Y gastric bypass |
| Intense conservative treatment | Active comparator | Intense conservative treatment. 8 week LCD followed by outpatient visits 1/ month Receives: Procedure: Intense conservative treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Mass Index (kg/m2)
Measured: 2 years after treatment initiation
Secondary outcomes (15)
Metabolic control
Glucose control (fP-Glc, fs-Insulin, HbA1c, Oral glucose tolerance test), Blood lipids (HDL, LDL, TG, Apo A, Apo B), Blood pressure (systolic and diastolic), Inflammation (LPK, CRP, Adiponectin, IL-6, TNF-alfa), liver function tests (AST, ALT, ALP, Bil)
Measured: 2, 5, 10 and 15 years after treatment initiation
Quality of life, generic
Mental and physical quality of life assessed by Short Form-36 (score 0-100, lower= more disability)
Measured: 2, 5, 10 and 15 years after treatment initiation
Obesity-specific quality of life
Obesity Problem scale- 9 items (score 0-100, higher score= more psychosocial impairment)
Measured: 2, 5, 10 and 15 years after treatment initiation
Socioeconomic development
Education, civil status, number of children, income, sick leave (from national registries)
Measured: 5, 10 and 15 years after treatment initiation
Health care consumption
In hospital care, outpatient care, prescribed medications; from national registries
Measured: 2, 5, 10 and 15 years after treatment initiation
Skeletal maturation and quality
Bone mineral content and bone mineral density will be assessed as well as blood markers for bone formation and resorption
Measured: 2, 5, 10 and 15 years after treatment initiation
Addictive behavior
Alcohol consumption, blood markers for alcohol consumption, drugs, brain response to visual stimuli
Measured: 2, 5, 10, 15 years after treatment initiation
Mental health
Depression, anxiety, self esteem, stability in neuropsychiatric disease (ADHD, ADD), psychiatric illness, OCD
Measured: 2, 5, 10 and 15 years after treatment initiation
Adverse events
Any adverse event (physical, mental or other)
Measured: 2, 5, 10 and 15 years after treatment initiation
Eating function
Assessment of meal pattern, dietary composition and gastrointestinal symptoms in relation to eating
Measured: 2, 5, 10 and 15 years after treatment initiation
Energy expenditure
Doubly labelled water, basic metabolic rate, 24h energy expenditure chamber 5 years
Measured: 5 years after treatment initiation
Body Mass Index, body weight, height. Additional assessments of primary outcome
Weight (kg) and height (m) will be combined to report BMI in kg/m2
Measured: 5, 10 and 15 years after treatment initiation
Cognitive Function
General cognitive functioning (IQ test- WISC-IV Wechsler Intelligence Scale for Children) Scale 1-200 where lower score means worse)
Measured: 1, 2 and 5 years after treatment initiation
Working memory
Memory (D-KEFS-Delis-Kaplan Executive Function System) several subscales 0-15, lower value means worse
Measured: 1, 2 and 5 years after treatment initiation
Attention
Attention (NEPSY- NEuroPSYcologic examination). Separate subscales for executive function and attention, language, memory and learning, sensorimotor, visuospatial processing, and social perception. Lower value means worse.
Measured: 1, 2 and 5 years after treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2015 (estimated)
- Study start15 Aug 2014
- Primary completionJun 2022 (estimated)
- Study completionJun 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Göteborg UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomisation between Bariatric surgery (mainly Roux-en-Y gastric bypass) or Intensive Medical treatment
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Torsten Olbers, MD, PhD, Principal investigator, University of Gothenburg, Dept of Surgical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02378259
- Sponsor's protocol ID
- 578-13
- Acronym
- AMOS2
- Status last verified
- Mar 2022
- First submitted
- 26 Aug 2014
- Last updated
- 25 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Jarvholm K, Gronowitz E, Janson A, Peltonen M, Sjogren L, Beamish AJ, Dahlgren J, Martensson J, Olbers T. Cognitive functioning in adolescents with severe obesity undergoing bariatric surgery or intensive non-surgical treatment in Sweden (AMOS2): a multicentre, open-label, randomised controlled trial. EClinicalMedicine. 2024 Feb 27;70:102505. doi: 10.1016/j.eclinm.2024.102505. eCollection 2024 Apr.
PubMed 38685922Jarvholm K, Janson A, Peltonen M, Neovius M, Gronowitz E, Engstrom M, Laurenius A, Beamish AJ, Dahlgren J, Sjogren L, Olbers T. Metabolic and bariatric surgery versus intensive non-surgical treatment for adolescents with severe obesity (AMOS2): a multicentre, randomised, controlled trial in Sweden. Lancet Child Adolesc Health. 2023 Apr;7(4):249-260. doi: 10.1016/S2352-4642(22)00373-X. Epub 2023 Feb 24.
PubMed 36848922Janson A, Jarvholm K, Gronowitz E, Sjogren L, Klaesson S, Engstrom M, Peltonen M, Ekbom K, Dahlgren J, Olbers T. A randomized controlled trial comparing intensive non-surgical treatment with bariatric surgery in adolescents aged 13-16 years (AMOS2): Rationale, study design, and patient recruitment. Contemp Clin Trials Commun. 2020 Jun 27;19:100592. doi: 10.1016/j.conctc.2020.100592. eCollection 2020 Sep.
PubMed 32637723
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AMOS2 (Adolescent Morbid Obesity Surgery)
- ClinicalTrials.gov ID
- NCT02378259
- Acronym / sponsor ID
- AMOS2 / 578-13
- Conditions
- Obesity, Diabetes, Hypertension, Steatohepatitis, Inflammation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Collaborators
- Sahlgrenska University Hospital, Karolinska University Hospital, Lund University
- Study start
- 15 Aug 2014 (actual)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Jun 2034 (estimated)
- First posted
- 4 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Severe childhood obesity is associated with both immediate and chronic health problems and a severe impact on psychosocial development. Medical and behavioural interventions rarely result in the significant, durable weight loss necessary to improve health outcomes.
This is a randomised clinical trial where 50 adolescents, 13-16 years of age, will be randomised to either early bariatric surgery (Roux-en-Y gastric bypass) or intense conservative treatment and possibly surgery after two years of non-surgical treatment or as they have become 18 years.
Detailed description
A multicentre randomised clinical trial where three tertiary referral hospitals recruit patients.
Patients and their parents receive information about the study at their paediatric clinic and at the trial web page (www.amos2.se). Standardised procedure, including signed informed consent.
Interventions
At the end of day of baseline examination patients are randomised to either of two arms:
- Bariatric surgery with regular follow up
- Optimised conservative treatment starting with an 8-week Low Calorie Diet period followed by tailored support and treatment by the multidisciplinary team with an intensity of at least one visits a month over at least 2 years
Patients in the conservative arm will be reassessed regarding interest of undergoing bariatric surgery two years after inclusion.
Sample Size A sample size of 50 (25+25) leaves a power of more than 95% to evaluate a possible superiority of >10% weight difference between the two groups, assuming a 15% standard deviation in weight loss over follow-up at 2.5% significance level.
This number also allows assessment for differences in cardiovascular risk factors with sufficient power and acceptable power for demonstrating differences in quality of life and cognitive functions.
3.6 Randomization The computerized random allocation is performed during the day of baseline examination and patients were informed of their assignment. Forty-nine patients have been included until May 2017, and the last patient will be operated on June 14th. Stratification has been performed according to the recruitment centre
3.8 Statistical Methods \& Additional Analyses Safety \& Efficacy Outcomes: Analyses will be by intention to treat, including all randomised patients. Difference in treatment effect will be evaluated with hazard ratio between the treatment groups, and the corresponding confidence interval will be calculated. For secondary outcomes, the incidence of comorbidities during follow-up will be evaluated using time-to-event models, and for continuous variables mixed models will be used to evaluate differences between the treatment groups.
Incremental cost-effectiveness analysis will be conducted by calculating the incremental cost-effectiveness ratio (ICER; dividing the between-group difference in costs with the between-group difference in quality-adjusted life-years (QALYs) as well as life-years). Probabilistic sensitivity analysis will be conducted and results presented in an ICER scatterplot and cost-effectiveness acceptability curve.
Follow-Up Clinical Data Collection: Study point are 6 weeks, 1 year, 2 years, and 5 years after the start of intervention. Weight, quality of life, and adverse events, as well as clinical data regarding treatments for co-morbidities. Blood sampling for assessment of nutritional deficiencies, glucose control, blood lipids and inflammation will be collected at baseline and 1, 2 and 5 years.
Cognitive functions: Assessments will be performed at baseline and 1 and 2 years after start of intervention.
Register-Based Data Collection and Health-Economic Outcomes: Collection and analysis of Swedish national health care and other official registries
We decided in the Study Steering Committee to change time points for long term follow up to be 5, 10 and 15 years after treatment initiation to better comply with standard schedules for clinical follow up in registers (instead of 7, 12 and 17y after treatment initiation).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomisation between Bariatric surgery (mainly Roux-en-Y gastric bypass) or Intensive Medical treatment
| Arm | Type | Receives |
|---|---|---|
| Bariatric surgery | Experimental | Procedure: Laparoscopic Roux-en-Y gastric bypassRoux-en-Y gastric bypass surgery |
| Intense conservative treatment | Active comparator | Procedure: Intense conservative treatmentIntense conservative treatment. 8 week LCD followed by outpatient visits 1/ month |
Who may qualify
- Ages
- 13 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Age 13-16 years
- BMI >35
- Failed comprehensive treatment for obesity > 1 year
- Passing assessment of psychologist
- Tanner 3 or more
Key exclusion criteria (6 listed)
- Monogenic obesity (for example Prader Willis, Laurence Moon-Bardet-Biedl)
- Obesity secondary to brain injury
- Severely mentally disabled
- Not eligible for general anesthesia
- Psychotic or other major psychiatric illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic Roux-en-Y gastric bypassBariatric surgery with Roux-en-Y gastric bypass as preferred option, possible laparoscopic Vertical Sleeve Gastrectomy | Procedure or surgery | Bariatric surgery |
| Intense conservative treatmentIntense medical treatment for obesity (behavioral treatment, dietary intervention, exercise, medication etc) 8 week period of Low Calorie Diet. Treatment intensity about 1 visit a month over 2 years | Procedure or surgery | Intense conservative treatment |
Primary outcome
Body Mass Index (kg/m2)
Time frame: 2 years after treatment initiation
15 secondary outcomes
Metabolic control
Time frame: 2, 5, 10 and 15 years after treatment initiation
Quality of life, generic
Time frame: 2, 5, 10 and 15 years after treatment initiation
Obesity-specific quality of life
Time frame: 2, 5, 10 and 15 years after treatment initiation
Socioeconomic development
Time frame: 5, 10 and 15 years after treatment initiation
Health care consumption
Time frame: 2, 5, 10 and 15 years after treatment initiation
Skeletal maturation and quality
Time frame: 2, 5, 10 and 15 years after treatment initiation
Addictive behavior
Time frame: 2, 5, 10, 15 years after treatment initiation
Mental health
Time frame: 2, 5, 10 and 15 years after treatment initiation
Adverse events
Time frame: 2, 5, 10 and 15 years after treatment initiation
Eating function
Time frame: 2, 5, 10 and 15 years after treatment initiation
Energy expenditure
Time frame: 5 years after treatment initiation
Body Mass Index, body weight, height. Additional assessments of primary outcome
Time frame: 5, 10 and 15 years after treatment initiation
Cognitive Function
Time frame: 1, 2 and 5 years after treatment initiation
Working memory
Time frame: 1, 2 and 5 years after treatment initiation
Attention
Time frame: 1, 2 and 5 years after treatment initiation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2022.
- Derived from this study: PubMed 38685922Jarvholm K, Gronowitz E, Janson A, Peltonen M, Sjogren L, Beamish AJ, Dahlgren J, Martensson J, Olbers T. Cognitive functioning in adolescents with severe obesity undergoing bariatric surgery or intensive non-surgical treatment in Sweden (AMOS2): a multicentre, open-label, randomised controlled trial. EClinicalMedicine. 2024 Feb 27;70:102505. doi: 10.1016/j.eclinm.2024.102505. eCollection 2024 Apr.
- Derived from this study: PubMed 36848922Jarvholm K, Janson A, Peltonen M, Neovius M, Gronowitz E, Engstrom M, Laurenius A, Beamish AJ, Dahlgren J, Sjogren L, Olbers T. Metabolic and bariatric surgery versus intensive non-surgical treatment for adolescents with severe obesity (AMOS2): a multicentre, randomised, controlled trial in Sweden. Lancet Child Adolesc Health. 2023 Apr;7(4):249-260. doi: 10.1016/S2352-4642(22)00373-X. Epub 2023 Feb 24.
- Derived from this study: PubMed 32637723Janson A, Jarvholm K, Gronowitz E, Sjogren L, Klaesson S, Engstrom M, Peltonen M, Ekbom K, Dahlgren J, Olbers T. A randomized controlled trial comparing intensive non-surgical treatment with bariatric surgery in adolescents aged 13-16 years (AMOS2): Rationale, study design, and patient recruitment. Contemp Clin Trials Commun. 2020 Jun 27;19:100592. doi: 10.1016/j.conctc.2020.100592. eCollection 2020 Sep.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Torsten Olbers, MD, PhD principal investigator
University of Gothenburg, Dept of Surgical Sciences
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic Roux-en-Y gastric bypass and Intense conservative treatment in people with Obesity and Diabetes, run by Göteborg University at 3 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 25 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Mass Index (kg/m2) (time frame: 2 years after treatment initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02378259, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2022.